How Useful Are Pre-sub Meetings With the FDA?

Making the most of your Q-submissions

How important is the FDA Pre-sub meeting? If saving time and money is important, then taking advantage of the FDA Pre-submission meeting program is key.

At a recent conference Kapstone attended, several FDA speakers emphasized the value of a Pre-sub meeting for saving precious resources, citing higher first-cycle clearance rates and fewer deficiency list cycles.

Pre-submission meetings are one type of Q-submission, which were lumped together in a non-binding 2017 guidance the FDA issued to provide medical device makers more clarity on the Investigational Device Exemption (IDE) process and for communicating with the FDA prior to submitting a list of applications including: Premarket Approval Applications, Humanitarian Device Exemptions and De Novo requests.

The guidance provides information on the logistics for submission, receipt, tracking and review of and response to communications requests, which are collectively tracked as Q-subs. Q-subs meetings include 7 request types: Pre-submission, Informational, Study Risk Determination, Agreement, Determination, Submission Issue, and Day 100 meetings.

Before you set up Pre-submission meeting, there are guidelines for what is considered appropriate for a meeting. Appropriate topics for a Pre-sub meeting include, be are not limited to:

• Specific preclinical testing needed for pre-market clearance or approval application and the performance testing required to support pre-market clearance.
• Identification of the applicable regulatory path for new devices.
• Formal designation of a device as a significant risk or non-significant risk.

The FDA is not inclined to meet with device makers to answer broad questions, and even if you have sharply focused questions, if they can be satisfactorily answered prior to the meeting date, the meeting may be cancelled.

To make the most of a FDA Pre-sub meeting, here are a few of the ways Kapstone Medical can help:

• We can advise you which type of Q-sub you need and when a Pre-submission meeting is appropriate. Working with your engineering and regulatory people, we can determine when criteria for a Pre-sub meeting have been met.
• We can then assist in preparing the needed Pre-sub meeting request package as well as the needed documentation to prepare for the meeting itself, including the product’s intended use statement, and product labels and other material that are needed.

• We also review and provide advice on proposed clinical or animal study protocols, pre-clinical lab testing, usability and performance testing. We can help develop the meeting presentation and even coach you with pre-meeting practice.

• Kapstone is also available to provide support during the meeting for notes, or as a participating consultant.

If you are ready to begin the FDA submission process, Kapstone Medical has the experience and expertise to assist you through all phases of the FDA process. For more information contact us today at (704) 843-7852 – or by email at info@kapstonemedical.com.